[Recalled] Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. — complaints of kinked acce
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. |
|---|---|
| Brand / manufacturer | Baxter Healthcare Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1121-2021 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 30 December 2020 |
| EAN / barcode | 07332414085216 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Baxter Healthcare Corporation
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.